Medication info

NPTika Tablets 90mg (Ticagrelor)

Prescription medicationTabletOralExpired
Ingredient · strength
Ticagrelor›Strength being verified
Manufacturer / importer
Daehan New Pharm Co., Ltd.
Appearance
Yellow, biconvex, round, film-coated tablet
Packaging
56 tablets/box [(14 tablets/PTP*4)]
Approval status
Expired

MFDS item code 201905800 · Approved 2019.08.16

This product's status changed to Expired on 2024.08.16. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Prevention of thrombotic cardiovascular events (including myocardial infarction) and stroke
Who takes it
Adults · Children
Adult dose
This medicine should not be used concomitantly with other ADP receptor inhibitors (ticlopidine, clopidogrel, prasugrel). Acute coronary syndrome: Administer an initial dose of 180mg, followed by 90mg twice daily. Treatment for 12 months is recommended unless discontinuation of this medicine is clinically necessary. Patients taking this medicine should also receive a maintenance dose of aspirin (75 - 150mg), unless specifically contraindicated. Patients with a history of myocardial infarction (occurring at least 1 year previously) who are at high risk of atherothrombotic cardiovascular events: Administer 60mg twice daily. Patients taking this medicine should also receive a maintenance dose of aspirin (75 - 150mg), unless specifically contraindicated. - Patients who took 90mg of this medicine or another ADP receptor inhibitor (ticlopidine, clopidogrel, prasugrel) during the first year after myocardial infarction may continue treatment with 60mg of this medicine. - Treatment with this medicine may also be initiated in patients within 2 years of myocardial infarction or within 1 year after discontinuing a previous ADP receptor inhibitor (ticlopidine, clopidogrel, prasugrel). - The safety and efficacy of this medicine were evaluated at 3 years of follow-up. Patients with type 2 diabetes who have undergone percutaneous coronary intervention (PCI) for coronary artery disease: Administer 60mg twice daily. Patients taking this medicine should also receive a maintenance dose of aspirin (75 - 150mg), unless specifically contraindicated. - For patients with acute coronary syndrome, refer to the corresponding dosage and administration. - Data on the safety and efficacy of treatment with this medicine for more than 3 years are limited. Patients with acute ischemic stroke or high-risk transient ischemic attack: Administer an initial dose of 180mg, followed by 90mg twice daily for 30 days. Patients taking this medicine should also receive a maintenance dose of aspirin (75 - 100mg), unless specifically contraindicated. An initial loading dose of aspirin (300-325mg) is recommended in patients with acute ischemic stroke or high-risk transient ischemic attack. Administration This medicine is administered orally and may be taken regardless of meals. For patients who have difficulty swallowing the tablets, crush this medicine into a fine powder, disperse it in half a glass of water, and drink it immediately; rinse the glass with another half glass of water and drink that as well. This mixture may also be administered through a nasogastric tube (CH8 or larger); it is important to flush the tube with water after administration. When switching from another antiplatelet agent to this medicine, start this medicine 24 hours after the last dose of the previous medicine. If a dose is missed, take only 1 tablet (the next scheduled dose) at the next scheduled dosing time. Patients with renal impairment No dose adjustment is necessary in patients with renal impairment. Patients with hepatic impairment No dose adjustment is necessary in patients with mild hepatic impairment. This medicine has not been studied in patients with severe hepatic impairment, and experience with its use in patients with moderate hepatic impairment is limited.
Child dose
Safety and efficacy in pediatric patients under 18 years of age have not been established (see “Other”).

Ingredients

Manufacturer
Daehan New Pharm Co., Ltd.

Efficacy & effects

Prevention of thrombotic cardiovascular events (including myocardial infarction) and stroke

  • Acute coronary syndrome
  • myocardial infarction
  • stroke
  • thrombotic cardiovascular events
  • Type 2 diabetes
  • coronary artery disease
  • acute ischemic stroke
  • transient ischemic attack
View approved original text

This medication helps reduce the incidence of thrombotic cardiovascular events, specifically deaths due to cardiovascular abnormalities, myocardial infarction, and stroke. It is particularly used in conjunction with aspirin for patients with acute coronary syndrome or for adult patients at high risk of thrombotic cardiovascular events who have a history of myocardial infarction for more than one year. It is also prescribed in combination for patients with Type 2 diabetes who have received treatment for coronary artery disease to reduce the risk of myocardial infarction and stroke. It is used alongside aspirin in patients who have had an acute ischemic stroke or high-risk transient ischemic attack to reduce the incidence of stroke. Thus, it is effectively used to prevent significant thrombotic events in various cardiovascular and cerebrovascular disease risk groups in combination with aspirin.

How to take

Adult dose

This medicine should not be used concomitantly with other ADP receptor inhibitors (ticlopidine, clopidogrel, prasugrel). Acute coronary syndrome: Administer an initial dose of 180mg, followed by 90mg twice daily. Treatment for 12 months is recommended unless discontinuation of this medicine is clinically necessary. Patients taking this medicine should also receive a maintenance dose of aspirin (75 - 150mg), unless specifically contraindicated. Patients with a history of myocardial infarction (occurring at least 1 year previously) who are at high risk of atherothrombotic cardiovascular events: Administer 60mg twice daily. Patients taking this medicine should also receive a maintenance dose of aspirin (75 - 150mg), unless specifically contraindicated. - Patients who took 90mg of this medicine or another ADP receptor inhibitor (ticlopidine, clopidogrel, prasugrel) during the first year after myocardial infarction may continue treatment with 60mg of this medicine. - Treatment with this medicine may also be initiated in patients within 2 years of myocardial infarction or within 1 year after discontinuing a previous ADP receptor inhibitor (ticlopidine, clopidogrel, prasugrel). - The safety and efficacy of this medicine were evaluated at 3 years of follow-up. Patients with type 2 diabetes who have undergone percutaneous coronary intervention (PCI) for coronary artery disease: Administer 60mg twice daily. Patients taking this medicine should also receive a maintenance dose of aspirin (75 - 150mg), unless specifically contraindicated. - For patients with acute coronary syndrome, refer to the corresponding dosage and administration. - Data on the safety and efficacy of treatment with this medicine for more than 3 years are limited. Patients with acute ischemic stroke or high-risk transient ischemic attack: Administer an initial dose of 180mg, followed by 90mg twice daily for 30 days. Patients taking this medicine should also receive a maintenance dose of aspirin (75 - 100mg), unless specifically contraindicated. An initial loading dose of aspirin (300-325mg) is recommended in patients with acute ischemic stroke or high-risk transient ischemic attack. Administration This medicine is administered orally and may be taken regardless of meals. For patients who have difficulty swallowing the tablets, crush this medicine into a fine powder, disperse it in half a glass of water, and drink it immediately; rinse the glass with another half glass of water and drink that as well. This mixture may also be administered through a nasogastric tube (CH8 or larger); it is important to flush the tube with water after administration. When switching from another antiplatelet agent to this medicine, start this medicine 24 hours after the last dose of the previous medicine. If a dose is missed, take only 1 tablet (the next scheduled dose) at the next scheduled dosing time. Patients with renal impairment No dose adjustment is necessary in patients with renal impairment. Patients with hepatic impairment No dose adjustment is necessary in patients with mild hepatic impairment. This medicine has not been studied in patients with severe hepatic impairment, and experience with its use in patients with moderate hepatic impairment is limited.

Child dose

Safety and efficacy in pediatric patients under 18 years of age have not been established (see “Other”).

Precautions

This medication prevents platelets in the blood from aggregating to form clots, thereby reducing the risk of cardiovascular diseases such as myocardial infarction or stroke. However, this medication may increase the risk of bleeding; therefore, patients with active bleeding or a history of intracranial hemorrhage should not take it. If surgery is planned, this medication should be discontinued at least 5 days prior, and bleeding risk should be considered during surgery. In addition, patients with hypersensitivity to this medication, severe liver impairment, or those that are using certain strong medications should avoid using it. Patients at high risk for bleeding, those who have recently undergone surgery, or those experiencing arrhythmias or breathing difficulties should use this medication with caution and consult a doctor. Particularly, patients with asthma or chronic obstructive pulmonary disease should be cautious as symptoms of dyspnea may worsen. This medication may affect blood test results, so it is essential to inform the medical staff if taking it during platelet function tests or for the diagnosis of heparin-induced thrombocytopenia. Women who are pregnant or nursing should consult a physician before use, as it may pose risks to the fetus or newborn. The safety and efficacy of this medication have not been established in children or patients under 18 years of age, so it is not recommended. Overdose increases the risk of bleeding and may lead to side effects such as arrhythmias or dyspnea, so immediate medical attention is necessary. This medication can interact with various other drugs; therefore, it is crucial to inform the medical staff of any other medications being taken, especially when combined with drugs that affect liver metabolism. Driving or operating machinery may cause dizziness or confusion, so caution is advised if symptoms occur. This medication should be kept out of reach of children and stored in its original container to maintain its quality.

Side effects

Bleeding, intracranial hemorrhage, ocular hemorrhage, ear bleeding, hypotension, dyspnea, respiratory tract bleeding, gastrointestinal bleeding, diarrhea, nausea, dyspepsia, constipation, retroperitoneal hemorrhage, skin bleeding, rash, itching, muscle bleeding, urinary tract bleeding, reproductive system bleeding, elevated serum creatinine, post-procedural bleeding, thrombotic thrombocytopenic purpura, bradyarrhythmia, heart block, angioedema, Cheyne-Stokes respiration, central sleep apnea, confusion, dizziness, syncope, headache, vertigo, ear bleeding, chest pain, pulmonary hemorrhage, pharyngitis, upper respiratory infection, asthma, pleural effusion, bronchitis, pneumothorax, pneumonia, pulmonary edema, weakness, anaphylactic shock, epistaxis, hemoptysis, hematoma, cerebral hemorrhage, spinal canal stenosis, dementia, migraine, paralysis, gait abnormalities, abdominal pain, rectal bleeding, anal bleeding, appendicitis, tendon disease, bursitis, rhabdomyolysis, diabetes, hyperkalemia, hyperglycemia, thirst, hepatitis, snoring, aneurysm, heart failure, cardiac rhythm disorders, palpitations, ventricular tachycardia, arrhythmia, ventricular fibrillation, cardiac arrest, myocardial infarction, urinary tract infection, kidney stones, cerebral ischemia, venous stenosis, cerebral infarction, vestibular disorder, malignant neoplasm of the male reproductive system, chemical poisoning, post-procedural hematoma, laceration, road traffic accident, trauma, nausea, vomiting, acute renal failure, anemia, tinnitus, ear pain, lymphadenopathy, eosinophilia, sexual dysfunction, prostatic hyperplasia, ovarian cyst, amenorrhea, vaginitis, loss of taste, abnormal sense of smell, elevated TSH, hypothyroidism, injection site reaction, injection site pain, insomnia, anxiety, memory impairment, erectile dysfunction, restlessness, orthostatic hypotension, hypertension exacerbation, cyanosis, atrial fibrillation, atrial arrhythmia, complete heart block, urinary incontinence, nocturia, chronic renal failure exacerbation, cystitis, urination abnormalities, renal cyst, urinary retention, conjunctivitis, diabetic retinopathy, cataract, abscess, oral candidiasis, herpes zoster, bacterial infection, esophageal candidiasis, blood iron deficiency, blood iron deficiency, lymphadenopathy, eosinophilia, contact dermatitis, fungal dermatitis, skin disease, erythematous rash, hyperkeratosis, acute urticaria, onychomycosis, hair loss, scleroderma, dermatofibroma, increased sweating, tendinitis, joint disease, chondrocalcinosis, spinal osteoarthritis, arthritis, urticaria, increased sweating, hypokalemia, hypocalcemia, unspecified lipid metabolism disorder, hyperkalemia, hypomagnesemia, hypoglycemia, elevated AST, elevated ALT, arrhythmia, ventricular tachycardia, atrial fibrillation, ventricular fibrillation, cardiac arrest, complete heart block, polyuria, dysuria, urinary tract infection, kidney stones, cystitis, renal cyst, urinary retention, cerebral infarction, intermittent claudication, phlebitis, conjunctival hyperemia, ocular pain, visual disturbances, arterial stenosis, angina, coronary thrombosis, cardiomyopathy, myocardial ischemia, cardiac compression.

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a sealed container to prevent exposure to air or moisture. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius. Proper storage can help preserve the medication's effectiveness.

Appearance and packaging

Appearance

Yellow, biconvex, round, film-coated tablet

Package unit

56 tablets/box [(14 tablets/PTP*4)]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.